510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K103037Substantially Equivalent

Ind Urinary Tract Infection (Uti) Test Strips

Ind Diagnostic, Inc., Delta, B.C., CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K103037 is the FDA 510(k) clearance record for IND URINARY TRACT INFECTION (UTI) TEST STRIPS, a class I device, cleared for Ind Diagnostic, Inc. on under FDA product code NGJ (Test, Nitrite, Urinary, Non-Quantitative, Over The Counter). FDA records list 8 510(k) clearances for Ind Diagnostic, Inc., from to . As of , FDA records show one recall naming K103037.

Clearance record

Decision date
Received
(551 days to decision)
Product code
NGJ Test, Nitrite, Urinary, Non-Quantitative, Over The Counter
Regulation
21 CFR 862.1510
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Ind Diagnostic, Inc. 1629 Fosters Way, Delta, B.C., CA
510(k) summary
Statement
Third party review
No

Clearances, product code NGJ

Trailing 12 months

FDA records hold no clearances under product code NGJ in the trailing twelve months.

FDA records show no clearances under product code NGJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NGJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260